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pt-141 melanocortin agonist rct 2026-04-03 PubMed

Bremelanotide Shows Strong Dose-Dependent Responder Rates for Low Sexual Desire

Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.

Background

Many women experience hypoactive sexual desire disorder (HSDD), characterized by persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity, causing significant distress. Current treatment options are limited, highlighting an unmet medical need. This Phase 2b dose-ranging study aimed to identify optimal dosing and evaluate responder rates for bremelanotide in women with HSDD.

Results

The study demonstrated a clear dose-response relationship, with higher doses of bremelanotide yielding superior responder rates. The 1.75 mg bremelanotide group showed the highest responder rate, with 43% of women experiencing a clinically meaningful improvement in sexual desire, compared to 18% in the placebo group (p<0.001). > The most significant finding was that bremelanotide at 1.75 mg led to a 2.4-fold increase in the proportion of women reporting reduced distress from low sexual desire compared to placebo (p<0.001). Furthermore, 28% of women in the 1.25 mg group and 21% in the 0.75 mg group also met responder criteria for desire improvement, indicating efficacy across multiple doses. Adverse events were generally mild to moderate, with nausea reported by 35% in the highest dose group versus 8% in placebo, and flushing by 22% versus 5%.

Why It Matters

This study provides crucial evidence supporting the efficacy and dose-response profile of bremelanotide as a potential treatment for HSDD. The identification of optimal dosing and significant responder rates suggest that bremelanotide could offer a valuable therapeutic option for women struggling with low sexual desire. These findings strongly support the progression of bremelanotide into larger Phase 3 clinical trials to further confirm its safety and efficacy in a broader population.


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Source: pubmed:31277966 · Ingested 2026-04-03 · Digest: gemini-2.5-flash